Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Lithotriptor, Biliary Mechanical
510(k) Number K964937
Device Name A LITHOTRIPTER-COMPATIBLE BASKET
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1537
Applicant Contact DANIEL J DILLON
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1537
Correspondent Contact DANIEL J DILLON
Regulation Number876.4500
Classification Product Code
LQC  
Date Received12/10/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-